Whoop
Quality Systems Specialist I, Digital Health
Boston, MA · Full-time
Sponsorship not specified$105k-$135kDetected 11 hours ago
Data AnalysisProduct ManagementProject ManagementFDA RegulatoryMedical DevicesCommunicationRegulatory Affairs
> stay_score
odds of building a lasting career here
33Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
No strong sponsorship signal in the public record yet. In the full product we resolve the exact legal entity and show its filing history with a confidence score — treat as unverified until then.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- WHOOP is looking for a Quality Systems Specialist I to be a core member of the Digital Health team at WHOOP.
- This role is based in the WHOOP office located in Boston, MA.
- Interested in the role, but don't meet every qualification?
Responsibilities
- Administer and maintain the eQMS, including document control, post-market workflows, training management, and system improvements.
- Own core quality system processes including complaint management, CAPA and nonconformances, training, change control, records management, and QMS-related post-market quality activities.
- Track and drive timely closure of CAPAs, nonconformances, audit findings, and other quality actions to ensure effectiveness and compliance.
- Maintain audit and inspection readiness, coordinate internal and external audits, support management reviews, and monitor quality metrics and trends to drive compliance and continuous improvement.
- Drive continuous improvement initiatives through data analysis, trend monitoring, root cause investigations, and process enhancements.
- Partner cross-functionally to support post-market surveillance activities, complaint trending, and quality data analysis to ensure ongoing product quality and regulatory compliance.
- Partner with Regulatory Affairs, Engineering, Product, and other functions to ensure quality system requirements are appropriately integrated into software development, product lifecycle management, and post-market activities.
- Develop, review, maintain, and improve SOPs, work instructions, forms, and other controlled documentation.
- Monitor evolving regulatory and quality requirements and support implementation of necessary QMS updates.
- This role owns key quality system processes and helps ensure compliance with applicable global regulations and standards.
Requirements
- Bachelor's Degree in Engineering, Life Sciences, or a related technical field.
- Experience supporting and maintaining electronic Quality Management Systems (eQMS).
- Experience supporting internal audits and third-party audits, including regulatory inspections.
- The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
- 2+ years of experience in Quality Management Systems, Quality Assurance, or related functions within the medical device, digital health, or software medical device industry.
- Working knowledge of ISO 13485 and 21 CFR Part 820/QMSR. Experience with MDSAP, IEC 62304, and other applicable medical device regulations and standards preferred.
- Experience owning and administering quality system processes such as CAPA, complaints, audits, training, and document control.
- Experience with SaMD, digital health technologies, software development lifecycle processes, and software-focused quality systems preferred.
- Strong organizational, communication, and project management skills.
- This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
- Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
- WHOOP is an Equal Opportunity Employer and participates in E-verify https://www.e-verify.gov/ to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
- The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
- At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
Nice to have
- Working knowledge of ISO 13485 and 21 CFR Part 820/QMSR.
Compensation
- The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
Benefits
- WHOOP is an advanced health and fitness wearable on a mission to unlock human performance.
- We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.
- As the Quality Systems Specialist I, you will maintain and continuously improve WHOOP's Quality Management System (QMS) for Software as a Medical Device (SaMD) and digital health products.
- Own and maintain QMS processes in compliance with ISO 13485, 21 CFR Part 820/QMSR, MDSAP, IEC 62304, and other applicable requirements supporting SaMD and digital health products.
Company info
- At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience.
This listing is sourced directly from Whoop's careers page and normalized into a canonical job model.